PMA P960007S011
- Device
- TRANSCYTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S011
- Product code
- MGR
- Decision date
- 1999-11-26
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval for changing the frequency of the in-process sterility testing conducted on the device.
Current openFDA PMA Record#
- Device
- TRANSCYTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S011
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-11-26
- Decision code
- APPR
- Date received
- 1999-08-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changing the frequency of the in-process sterility testing conducted on the device.